US4490420A - Medical bag and method for manufacturing the same - Google Patents

Medical bag and method for manufacturing the same Download PDF

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Publication number
US4490420A
US4490420A US06/422,943 US42294382A US4490420A US 4490420 A US4490420 A US 4490420A US 42294382 A US42294382 A US 42294382A US 4490420 A US4490420 A US 4490420A
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US
United States
Prior art keywords
sheets
pair
resin
bag
silicone resin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
US06/422,943
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English (en)
Inventor
Takao Yoshida
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Assigned to TERUMO KABUSHIKI KAISHA T/A TERUMO CORPORATION, A CORP. OF JAPAN reassignment TERUMO KABUSHIKI KAISHA T/A TERUMO CORPORATION, A CORP. OF JAPAN ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: YOSHIDA, TAKAO
Application granted granted Critical
Publication of US4490420A publication Critical patent/US4490420A/en
Anticipated expiration legal-status Critical
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y10T428/1341—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24802—Discontinuous or differential coating, impregnation or bond [e.g., artwork, printing, retouched photograph, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31652—Of asbestos
    • Y10T428/31663—As siloxane, silicone or silane

Definitions

  • the present invention relates to a medical bag and a method for manufacturing the same, and more particularly, to an improvement in a medical bag formed from sheets which exhibit a blocking tendency at high temperatures.
  • Flexible medical bags such as blood bags are currently made of soft polyvinyl chloride or polyolefin-type resins. These medical bags must be sterilized (generally sterilized by steam autoclaving) for hygiene.
  • the resins as described above exhibit a blocking tendency at high temperatures during sterilization; the inner surfaces of the sheets of these resins adhere to each other.
  • sterilization is conventionally performed while introducing air into the bag. However, this results in poor workability.
  • a blood bag is made of polyvinyl chloride
  • a substance which acts as an anticoagulant for platelets to polyvinyl chloride, and to transfer this substance to the inner and outer surfaces of the bag.
  • this method does not provide sufficiently good results.
  • elution of a plasticizer which is a factor in degrading the storage characteristics of the platelets cannot be prevented.
  • Other measures must be taken to prevent elution of the plasticizer.
  • a medical bag comprised of a pair of sheets which exhibit a blocking tendency at high temperatures, a non-fluid layer of an at least partially crosslinked silicone resin being formed in the form of spots or islands on at least one of two opposing surfaces of said pair of sheets, and said pair of sheets being sealed by heat sealing at those parts of the peripheries thereof where said non-fluid layer is not formed.
  • the sheets are generally made of soft polyvinyl chloride or other soft plastics.
  • the non-fluid layer of silicone resin layer is preferably formed on both opposing surfaces of the pair of sheets.
  • the partially crosslinked silicone resin mainly contains alkylsiloxane units and includes an aminoalkylsiloxane-dimethylsilicane copolymer which contains, for example, 5 to 20% by weight of aminoalkylsiloxane units and 95 to 80% by weight of dimethylsiloxane units.
  • a medical bag of the present invention may be manufactured by preparing a pair of sheets which exhibit a blocking tendency at high temperatures, coating a reactive silicone resin solution in the form of spots or islands on one surface of the sheets, drying the resin layer to at least partially crosslink the resin to render it non-fluidized, superposing the sheets upon each other, and sealing by heat sealing those parts of the sheets where the resin layer is not formed, so as to provide a medical bag.
  • the resin solution may be coated by spray coating or printing.
  • the sheets are made of a plastic which has a high-frequency welding property such as polyvinyl chloride, sealing is preferably performed with high-frequency waves.
  • FIGS. 1A to 1C are perspective views showing in sequential order the method for manufacturing a medical bag according to the present invention.
  • FIG. 2 is a plan view of the medical bag according to the present invention.
  • the present inventors have made extensive studies in order to solve the problem of blocking between the inner surfaces of the sheets of a medical bag during steam autoclaving sterilization. As a result of such studies, it has been found that certain types of silicone resins can prevent blocking, improve the storage characteristics of platelets, and reduce to the minimum elution of a plasticizer when soft polyvinyl chloride is used for the sheets.
  • a silicone resin to be used herein must be reactive and must be nontoxic to human bodies. If the bag of the present invention is used as a blood bag, the resin must also serve to prevent adhesion of platelets to the bag.
  • Reactive silicone resins which satisfy these requirements may be easily selected from known silicone resins. Examples of such reactive silicone resins which satisfy these requirements include those which mainly contain alkylsiloxane units such as aminoalkylsiloxane-dimethylsiloxane copolymers and which are described, for example, in Japanese Patent Publication No. 46-3627. Such a copolymer contains 5 to 20% by weight of aminoalkylsiloxane units and 95 to 80% by weight of dimethylsiloxane units. Such a reactive silicone resin is commercially available in the form of a solution.
  • the reactive silicone resin is coated on at least one of the opposing surfaces of a pair of sheets making up a bag, so as to prevent blocking and to improve the storage characteristics of platelets.
  • the reactive silicone resin is coated continuously over the entire surface of the sheet, sealing of the bag is prevented by the presence of the silicone resin, and a bag cannot be manufactured.
  • the silicone resin is coated in the form of small spots or islands. More specifically, the silicone resin is coated in the form of spots or islands to leave a continuous non-coated part of the sheet. The non-coated part (i.e. at the matrix portion) is then heat-sealed to provide a desired bag.
  • the silicone resin is preferably coated on both opposing surfaces of the sheets to obtain better effects.
  • a pair of elongated sheets 11 and 12 are prepared as shown in FIGS. 1A and 1B.
  • These elongated sheets 11 and 12 are made of a thermoplastic resin (e.g., polyvinyl chloride, or olefin-based resin such as polyethylene) and an ethylene-vinyl acetate copolymer which has a blocking tendency at high temperatures (110° to 130° C.) during steam autoclaving sterilization.
  • a reactive silicone resin solution layer 13 (partially shown) is formed in the form of separate small spots or islands on the entire surfaces 11a and 12a of sheets 11 and 12, respectively.
  • the reactive silicone resin solution layer 13 may be formed in the form of small spots or islands by dissolving a reactive silicone resin in Freon (trade name for fluorohydrocarbon by Du Pont de Nemours) in a low concentration (e.g., 2.5%) and spraying the resultant solution, or by preparing a relatively concentrated solution and printing therewith.
  • Freon trade name for fluorohydrocarbon by Du Pont de Nemours
  • the reactive silicone resin solution layer 13 formed on each of sheets 11 and 12 is dried at room temperature (about for 15 minutes). Thereafter, the sheets 11 and 12 are superposed upon each other such that the surfaces 11a and 12a thereof oppose each other, as shown in FIG. 1C.
  • several sets of exhaust ports 14 and 15 and a transfusion tube 16 are inserted, with predetermined distances therebetween, between the sheets 11 and 12 in the direction perpendicular to the longitudinal direction thereof.
  • the portions of the sheets that correspond to peripheries of the bag are then sequentially heat-sealed.
  • Heat sealing is preferably performed with high-frequency waves if the sheets 11 and 12 are made of a plastic which has a high-frequency welding property such as polyvinyl chloride or an ethylene-vinyl acetate copolymer.
  • bags with a sealed periphery 17 is manufactured as shown in FIG. 2.
  • a pair of sheets formed of soft polyvinyl chloride which contained dioctyl phthalate (DOP) as a plasticizer were prepared.
  • DOP dioctyl phthalate
  • a commercially available reactive silicone resin solution containing 50% resinous contents of aminoalkylsiloxane and dimethylsiloxane was diluted with Freon to prepare a 2.5% reactive silicone resin solution.
  • the resin solution was then sprayed with a spray gun onto one surface of each sheet and was naturally cooled to crosslink and cure the resin. Thus, separate small spots or islands of crosslinked silicone resin were formed on the sheets (this was confirmed with a microphotograph).
  • the resultant sheets were superposed upon each other such that the silicone resin layers opposed each other.
  • the peripheries of the sheets were then heat-sealed by high-frequency waves to prepare a blood collection bag.
  • the medical bag of the present invention is comprised of a pair of sheets of a plastic which exhibits a blocking tendency at high temperatures during steam autoclaving sterilization.
  • layers of at least partially crosslinked reactive silicone resin are formed on the inner surfaces of the bag, the inner surfaces of the bag may not adhere to each other.
  • the silicone resin layers prevent adhesion or elongation of the platelets, the storage characteristics of the platelets are improved when the medical bag is used as a blood bag.
  • the silicone resin serves to prevent elution of the plasticizer, providing an excellent blood bag.
  • the silicone resin may not elute into the infusion solution or into blood, thus providing a safe medical bag.
  • silicone resin layers are formed in the form of spots or islands, heat sealability is substantially equivalent to that obtained when the resin layers are not formed. Therefore, manufacture of the bag is easy. Since the resin layers are non-fluid, handling during manufacture is easy.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Coating Of Shaped Articles Made Of Macromolecular Substances (AREA)
  • Laminated Bodies (AREA)
US06/422,943 1982-03-24 1982-09-24 Medical bag and method for manufacturing the same Expired - Fee Related US4490420A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP57-46779 1982-03-24
JP57046779A JPS58163373A (ja) 1982-03-24 1982-03-24 医療用バツグおよびその製造方法

Publications (1)

Publication Number Publication Date
US4490420A true US4490420A (en) 1984-12-25

Family

ID=12756807

Family Applications (1)

Application Number Title Priority Date Filing Date
US06/422,943 Expired - Fee Related US4490420A (en) 1982-03-24 1982-09-24 Medical bag and method for manufacturing the same

Country Status (8)

Country Link
US (1) US4490420A (en])
JP (1) JPS58163373A (en])
BE (1) BE894746A (en])
DE (2) DE3238835C2 (en])
ES (1) ES277103Y (en])
FR (1) FR2523847B1 (en])
IT (1) IT1152924B (en])
SE (1) SE452111B (en])

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4582762A (en) * 1983-11-01 1986-04-15 Sumitomo Bakelite Company Ltd. Soft vinyl chloride resin-silicone composite shaped article
US4600613A (en) * 1983-04-25 1986-07-15 Terumo Kabushiki Kaisha Medical bag
US4657541A (en) * 1984-06-07 1987-04-14 Terumo Kabushiki Kaisha Medical instrument
US4686124A (en) * 1983-12-12 1987-08-11 Sumitomo Bakelite Company Ltd. Thermoplastic resin-silicone rubber composite shaped article
US4692200A (en) * 1985-07-30 1987-09-08 Advanced Cardiovascular Systems, Inc. Self-venting balloon dilatation catheter and method
US4735832A (en) * 1984-05-11 1988-04-05 Terumo Kabushiki Kaisha Container made of synthetic resin and method for manufacture thereof
US4837047A (en) * 1984-07-16 1989-06-06 Sumitomo Bakelite Co., Ltd. Container and method for storing blood
US5514431A (en) * 1993-12-30 1996-05-07 Dai Nippon Printing Co., Ltd. Air bag and method for making the air bag
US5578028A (en) * 1993-09-17 1996-11-26 Pall Corporation Method and system for collecting, processing, and storing blood components
US6627034B1 (en) * 1999-07-27 2003-09-30 North Carolina State University Pattern release film between two laminated surfaces
US20110143587A1 (en) * 2009-12-11 2011-06-16 Aerovironment , Inc. Waterproof electrical connector and system
CN102555282A (zh) * 2010-12-20 2012-07-11 泰尔茂株式会社 医疗用袋单个包装体的制造方法和医疗用袋单个包装体
USD675106S1 (en) * 2011-12-14 2013-01-29 The Proctor & Gamble Company Over the counter medicinal container with surface ornamentation
CN104771804A (zh) * 2015-03-04 2015-07-15 俞金慧 一种不用吊着的输液器

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6212303U (en]) * 1985-07-08 1987-01-26
JPS63186652A (ja) * 1987-01-29 1988-08-02 味の素株式会社 バツグ入り医薬用液剤
US4790815A (en) * 1987-03-12 1988-12-13 Baxter Travenol Laboratories, Inc. Heat sterilizable plastic container with non-stick interior surfaces
DE19536546A1 (de) * 1994-03-29 1997-04-03 Fresenius Ag Medizinischer Beutel

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3523050A (en) * 1967-03-10 1970-08-04 Polaroid Corp Process for preparing envelope structures
US3849359A (en) * 1971-04-20 1974-11-19 Wacker Chemie Gmbh Agents for the manufacture of organopolysiloxane coatings which repel adhesive substances
US4049873A (en) * 1975-01-28 1977-09-20 Imperial Chemical Industries Limited Surface treating compositions
US4119267A (en) * 1976-08-18 1978-10-10 Agis Frank Kydonieus Blood and intravenous solution bag
US4154714A (en) * 1975-03-05 1979-05-15 Wacker-Chemie Gmbh Adhesive repellent coatings and substrates coated therewith
US4337768A (en) * 1980-02-26 1982-07-06 Toray Industries, Inc. Polyvinyl chloride sheet and method of making the same

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3424218A (en) * 1966-12-07 1969-01-28 Garrett Corp Medical material container
DE2421433A1 (de) * 1974-05-03 1975-11-13 Braun Melsungen Ag Flachbeutel aus folien von thermoplastischen kunststoffen fuer biologische und therapeutische fluessigkeiten
JPS54156083A (en) * 1978-05-31 1979-12-08 Shin Etsu Chem Co Ltd Composite molded article of vinyl chloride resin and silicone
US4228032A (en) * 1978-11-06 1980-10-14 Dow Corning Corporation Method of storing blood and a blood storage bag therefore
GB2065067B (en) * 1979-10-15 1983-06-22 Toppan Printing Co Ltd Laminated bags

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3523050A (en) * 1967-03-10 1970-08-04 Polaroid Corp Process for preparing envelope structures
US3849359A (en) * 1971-04-20 1974-11-19 Wacker Chemie Gmbh Agents for the manufacture of organopolysiloxane coatings which repel adhesive substances
US4049873A (en) * 1975-01-28 1977-09-20 Imperial Chemical Industries Limited Surface treating compositions
US4154714A (en) * 1975-03-05 1979-05-15 Wacker-Chemie Gmbh Adhesive repellent coatings and substrates coated therewith
US4119267A (en) * 1976-08-18 1978-10-10 Agis Frank Kydonieus Blood and intravenous solution bag
US4337768A (en) * 1980-02-26 1982-07-06 Toray Industries, Inc. Polyvinyl chloride sheet and method of making the same

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4600613A (en) * 1983-04-25 1986-07-15 Terumo Kabushiki Kaisha Medical bag
US4645482A (en) * 1983-04-25 1987-02-24 Terumo Kabushiki Kaisha Method of manufacturing medical bag
US4582762A (en) * 1983-11-01 1986-04-15 Sumitomo Bakelite Company Ltd. Soft vinyl chloride resin-silicone composite shaped article
US4814231A (en) * 1983-12-12 1989-03-21 Sumitomo Bakelite Company Limited Thermoplastic resin-silicone composite shaped article
US4686124A (en) * 1983-12-12 1987-08-11 Sumitomo Bakelite Company Ltd. Thermoplastic resin-silicone rubber composite shaped article
US4834721A (en) * 1983-12-12 1989-05-30 Sumitomo Bakelite Company Ltd. Thermoplastic resin silicone composite shaped article
US4735832A (en) * 1984-05-11 1988-04-05 Terumo Kabushiki Kaisha Container made of synthetic resin and method for manufacture thereof
US4657541A (en) * 1984-06-07 1987-04-14 Terumo Kabushiki Kaisha Medical instrument
US4837047A (en) * 1984-07-16 1989-06-06 Sumitomo Bakelite Co., Ltd. Container and method for storing blood
US4692200A (en) * 1985-07-30 1987-09-08 Advanced Cardiovascular Systems, Inc. Self-venting balloon dilatation catheter and method
US6045546A (en) * 1993-09-17 2000-04-04 Pall Corporation Method and system for collecting, processing, and storing blood components
US5578028A (en) * 1993-09-17 1996-11-26 Pall Corporation Method and system for collecting, processing, and storing blood components
US5578027A (en) * 1993-09-17 1996-11-26 Pall Corporation Method and system for collecting, processing, and storing blood components
US5514431A (en) * 1993-12-30 1996-05-07 Dai Nippon Printing Co., Ltd. Air bag and method for making the air bag
US6627034B1 (en) * 1999-07-27 2003-09-30 North Carolina State University Pattern release film between two laminated surfaces
US20110143587A1 (en) * 2009-12-11 2011-06-16 Aerovironment , Inc. Waterproof electrical connector and system
CN102555282A (zh) * 2010-12-20 2012-07-11 泰尔茂株式会社 医疗用袋单个包装体的制造方法和医疗用袋单个包装体
CN102555282B (zh) * 2010-12-20 2016-04-27 泰尔茂株式会社 医疗用袋单个包装体的制造方法和医疗用袋单个包装体
USD675106S1 (en) * 2011-12-14 2013-01-29 The Proctor & Gamble Company Over the counter medicinal container with surface ornamentation
CN104771804A (zh) * 2015-03-04 2015-07-15 俞金慧 一种不用吊着的输液器

Also Published As

Publication number Publication date
SE8205932D0 (sv) 1982-10-19
DE8229420U1 (de) 1983-03-03
SE452111B (sv) 1987-11-16
IT8223841A0 (it) 1982-10-20
FR2523847A1 (fr) 1983-09-30
JPS58163373A (ja) 1983-09-28
JPH0118741B2 (en]) 1989-04-07
BE894746A (fr) 1983-02-14
DE3238835C2 (de) 1985-09-12
DE3238835A1 (de) 1983-10-06
SE8205932L (sv) 1983-09-25
IT1152924B (it) 1987-01-14
FR2523847B1 (fr) 1988-04-22
ES277103U (es) 1984-08-01
ES277103Y (es) 1985-03-16

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